Kornimate/medical-research-clean huggingface dataset:
surgery followed by risk-directed post-operative adjuvant therapy for hpv-related oropharynx squamous cell carcinoma: "the minimalist trial (mint)"

Conditions: HPV Related Oropharyngeal Squamous Cell Carcinoma

Summary: the overarching goal of the mint trial is to reduce treatment-related toxicity while maintaining efficacy. patients with hpv-related oropharyngeal squamous cell carcinoma (opscc) will undergo resection of the primary tumor site and involved/at risk regional neck nodes.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed hpv-related stages i-iii opscc (8th edition of ajcc/uicc staging manual) or hpv-related neck node with unknown primary. hpv-related may be defined by p16 ihc stain and/or hpv-ish or pcr using standard definitions of positive and negative test results. * primary tumor that will be resected via a transoral oral approach (conventional surgery, transoral laser microsurgery, transoral robotic surgery) * eastern cooperative oncology group (ecog) performance status (ps) 0-2. * normal organ and marrow function defined as: * creatinine clearance \> 50 cc/min. * anc \> 1,000/mcl. * platelet count \>100,000/mcl. * at least 18 years of age. * women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document. exclusion criteria: * prior curative therapy for hnscc. * patient must not have known distant metastatic disease at presentation. * history of prior invasive malignancy diagnosed within 2 years prior to study enrollment; exceptions are malignancies with a low risk of metastasis or death (e.g., expected 5-year overall survival (os) \> 90%) that were treated with an expected curative outcome, such as squamous cell carcinoma of the skin, in-situ carcinoma of the cervix uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental histological finding of prostate cancer (tnm stage of t1a or t1b). * receiving any other investigational agents. * uncontrolled serious inter-current illness or serious psychiatric illness/social situations that would limit compliance with study requirements. * pregnant and/or breastfeeding. a negative serum or urine pregnancy test is required at screening for all female patients of childbearing potential.
a study of ion537 in patients with molecularly selected advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the purpose of this study is to evaluate the safety and establish the maximum tolerated dose (mtd) and recommended phase 2 dose (rp2d) of ion537 when administered by intravenous infusion in patients with advanced solid tumors.

this is a single center, open label, non-randomized, phase 1, two-part study of ion537 in up to 102 participants. part 1 of the study consists of sequential cohort, dose escalation in patients with advanced solid tumors. part 2 is dose expansion in patients with molecularly selected advanced solid tumors. in total, the study includes up to 102 participants. the study will consist of a 30-day screening period, a treatment period consisting of sequential consecutive treatment cycles (each cycle will be of 28 days) and a post-treatment follow-up period of at least 28 days following the last dose of study drug.

Eligibility criteria:
inclusion criteria: 1. males and females ≥ 18 years old 2. participants must have histological diagnosis of local advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent 3. participants must be in need of systemic treatment for their cancer and either are refractory to or have failed treatment with, are intolerant to or have refused, or are not otherwise a candidate, in the opinion of the investigator, for any of the currently available established therapies 4. participants must have available a fresh or recent tumor tissue sample from a diagnostic biopsy/surgery or a metastatic tumor biopsy; 5. participants must have measurable disease by response evaluation criteria in solid tumors (recist) v1.1; or participants may have bone metastatic disease evaluable by prostate cancer working group 2 (pcwg2) for participants with metastatic castration-resistant prostate cancer (mcrpc), or according to the tumor evaluation criteria best suited and accepted for the tumor type being evaluated 6. participants must have an eastern cooperative oncology group (ecog) performance status (ps) 0 or 1 7. participants must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures exclusion criteria: 1. known history or positive test for human immunodeficiency virus (hiv), hepatitis c virus (hcv) or chronic hepatitis b virus (hbv) infection. 2. active infection requiring intravenous (iv) antibiotics 3. history of cerebrovascular accident (cva), myocardial infarction or unstable angina within the previous 6 months before starting therapy. 4. participants with uncontrolled type i or ii diabetes mellitus (dm); uncontrolled dm 5. participants with prior anti-cancer therapy within 2 weeks prior to study enrollment or prior radiation therapy within 2 weeks prior to study enrollment.

Keywords: solid tumors advanced solid tumors
detection of cholesteatoma using diffusion magnetic resonance imaging

Conditions: Cholesteatoma

Summary: cholesteatoma is a retraction pocket lined with squamous epithelium lined with keratin debris occurring within pneumatized spaces of the temporal bone. cholesteatomas have a propensity for growth, bone destruction, and chronic infection.high-resolution computerized tomography is the method of choice for imaging the middle ear .

in patients with recurrent cholesteatoma, computerized tomography can show the extent of cholesteatoma in relation to the ossicles and mastoid process,but computerized tomography has a high negative predictive value if neither a soft-tissue mass nor bony destructions are shown.however, if a soft-tissue mass in the middle ear is seen on computerized tomography, diagnosis of the mass is not possible because cholesteatoma, mucoid secretion, granulation tissue and cholesterol granuloma can not be differentiated from one another on computerized tomography. standard magnetic resonance imaging shows tissues better than computerized tomography,therefore in patients with cholesteatoma, magnetic resonance imaging plays a complementary role to computerized tomography in the diagnostic workup, although computerized tomography provides excellent bony resolution for showing the anatomy, magnetic resonance imaging provides specificity in characterizing soft-tissue abnormalities shown on computerized tomography,how ever standard magnetic resonance imaging frequently fails to allow differentiation of cholesteatoma from other soft tissues or mucoid secretions, particularly in patients who had ear surgery. recent studies of diffusion weighted magnetic resonance imaging show that it is sensitive to cholesteatoma tissue.recent studies highlights the ability of diffusion weighted magnetic resonance imaging in differentiating cholesteatoma from granulation tissue in patients who have undergone mastoidectomy and also these imaging modalities help in the diagnosis of residual cholesteatoma. diffusion weighted magnetic resonance imaging play an important role in diagnosis of retraction pockets . diffusion weighted magnetic resonance imaging is based on the principle of random microscopic motion (brownian motion) of water molecules.this "diffusion" of water molecules differs in each biological tissue, for example water molecules in cholesteatoma are less mobile giving rise to a hyper-intense signal, while in other tissues as granulation tissues, water molecules are more mobile thus appear less intense on diffusion weighted magnetic resonance imaging sequence.

Eligibility criteria:
inclusion criteria: * • all patients presented with suspected primary cholesteatoma ,high risk retraction pockets ,suspected recurrent or residual cholesteatoma after surgery . exclusion criteria: * contraindication to magnetic resonance imaging (e.g., pacemaker, metallic implant,cochlear implant or claustrophobia).
microeeg for neonatal apnea, bradycardia and desaturation

Conditions: Apnea; Bradycardia; Premature Birth; Seizures

Summary: the study utilizes microeeg (a novel miniaturized, fda approved eeg device) to prospectively investigate the cerebral electrical activity of infants with apnea, bradycardia and desaturation events. this project will also assess the feasibility of using the microeeg device in the neonatal intensive care unit (nicu) setting and the feasibility of remote centralized interpretation in this setting.

most preterm infants have episodes of apnea (cessation of breathing), bradycardia (low heart rate), and desaturations (low levels of oxygen in the blood) (abd events). the resolution of abd episodes depends to a large extent on the maturation of the central nervous system (cns). the electroencephalogram (eeg) is a reliable and noninvasive tool for recording the electrical activity of the cns. the relationship between abd events and cerebral electrical activity has not been well investigated. the investigators seek to examine the relationship between eeg findings and the resolution of abd events in the developing premature infant. to investigate this relationship and obtain findings which are relevant to clinical care, a variety of obstacles need to be overcome. among these obstacles is the high cost of standard eeg machines, inability of most standard machines to operate in electrically-noisy environments such as the nicu, and the absence of full-time coverage neurologists for prompt eeg interpretation. the investigators seek to determine the feasibility of obtaining an artifact-free eeg in the nicu with accurate detection of background rhythm abnormalities. the investigators will utilize an existing digital wireless telemetry unit, the "microeeg" for the nicu for this purpose. the microeeg device is specifically designed to overcome obstacles to standard eeg recording. to address the shortage of trained pediatric neurophysiologists, the investigators will investigate the feasibility of a case management system for centralized eeg interpretation using off-site neurologists. finally, the investigators will examine the inter-rater reliability of eeg interpretation in the developing premature infant. this will allow the development of consensus guidelines for eeg interpretations.

Eligibility criteria:
inclusion criteria: 1. gestational age (ga) 24-32 weeks 2. postnatal ages 0-30 days. the patients will be recruited upon manifesting one of the following * apneas (cessation of breathing \> 10 seconds) x2 in a 12 hour span * bradycardias (hr \< 100/min) x2 in 12 hours * oxygen desaturations (\<80%) x 2 in 12 hours * a single abd event that does not resolve with stimulation or an increase in fractional oxygen delivery (fio2). exclusion criteria: 1. major malformations 2. the infant has exposed dermis on the scalp due to immaturity 3. any scalp skin lesions such as pustules, large abrasions the patient will be withdrawn if * informed consent is withdrawn * adverse events (i.e..scalp lesions) develop

Keywords: eeg preterm infants neonate wireless
comparative assessment of efficacy & safety of sacubitril/valsartan versus ramipril in patients with renal dysfunction hospitalized with acute decompensated heart failure

Conditions: Acute Decompensated Heart Failure (ADHF); Chronic Kidney Disease (CKD)

Summary: sacubitril/valsartan is an established medication for heart failure. however, data still lags in its use in heart failure patients with chronic kidney disease. sacubitril/valsartan is manufacturer-labeled for use in patients with egfr \< 30 ml/min/1.73 m2 at an initial dose of 24/26mg twice daily. however, to the best of our knowledge, the concept of sacubitril/valsartan or acei in patients with chronic kidney disease \& presenting with decompensated heart failure has not yet been explored fully.


Eligibility criteria:
inclusion criteria: all the following should be met: * acute decompensated heart failure (adhf) * left ventricular ejection fraction (lvef) below 40% * renal dysfunction; defined as egfr of 30ml/min/1.73m2 to less than 60ml/min/1.73m2 in relation to the level of urinary albumin/creatinine ratio (uacr) based on the 2024 kidney disease: improving global outcomes (kdigo) clinical practice guidelines for the evaluation and management of ckd. * a minimum blood pressure (bp) ≥ 105/60 mmhg. * independent of any inotropic or vasopressor support in the previous 24 hours before inclusion and randomization. * no more than 72 hours had passed since admission to the heart failure unit. * patients should have had a new york heart association (nyha) functional class ii-iv, in addition to symptoms of volume overload at the time of presentation to the emergency room. exclusion criteria: * patients who were on sacubitril/valsartan or acei/ angiotensin receptor blocker (arb) prior to inclusion. * patients with aki on presentation or in the last 3 months or had ≥ 2 hospital admissions in the last 12 months for aki. * history of known or suspected hypersensitivity, contraindications, or intolerance to any of the study drugs including acei, arb or sacubitril (neprilysin inhibitor). * requirement for double treatment with both acei and arb. * serum potassium (k+) level ≥ 5.0 mmol/l at randomization. * a recent major adverse cardiovascular/cerebrovascular event within 1 month (acute coronary syndrome, stroke, transient ischemic attack, etc.). * patients with hemodynamically significant primary valvular lesion. * known hepatic impairment with a model for end-stage liver disease (meld) score \>10. 23 * history of malignancy of any organ system within the past year with a life expectancy \< 1 year.
solfa study to explore the thrombogenicity of a dialyzer

Conditions: End Stage Renal Disease on Dialysis

Summary: prospective, multicenter, randomized, crossover, non-masked study to evaluate the impact on the thrombogenicity of the haemodialysis circuit by comparing synthetic haemodialysers against the ata membrane of the solacea™.

this is a prospective, multicenter, randomized, crossover, non-masked study that included 32 patients from 4 spanish hospitals. the objective of the present work is to evaluate the impact on the thrombogenicity of the haemodialysis circuit by comparing synthetic haemodialysers against the ata membrane of the solacea™. study population. patients over 18 years of age in a chronic haemodialysis program who had been on dialysis for more than three months were included. all patients provided informed consent. the study was approved by the local ethics committee and was conducted according to the principles of the declaration of helsinki. the exclusion criteria were allergies to synthetic membranes and allergies to heparin, patients receiving anticoagulant treatment, women pregnant, breastfeeding or patients with cognitive impairment. in each of the two phases of six consecutive two-week hd sessions, patients were dialyzed according to their usual schedule with the haemodialyser assigned after randomization (synthetic vs ata membrane). during the six sessions of both phases, the dose of heparin was progressively reduced, 100% usual heparin dose in the first session until sixth session without heparin. after each session, carried out a visual inspection of the venous chamber and the haemodialyser and assigned a coagulation score previously published. dialyser score from 0 (completly clean, 0% coagulated fibers) to 4 (100% coagulated fibers). venous chamber score from 0 (clean, without clotting) to 3 (complete oclusión, dialysis is not possible). demographic data and dialysis parameters were also collected. the dialyzers from 8 patients were collected at the beginning and end of each study arm and scanned with a reference non-invasive micro-ct (computed tomography) scanning technique.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age. * patients in a chronic haemodialysis program who had been on dialysis for more than three months were included. * patients provided informed consent. exclusion criteria: * allergies to synthetic membranes * allergies to heparin * patients receiving anticoagulant treatment * women pregnant * breastfeeding * patients with cognitive impairment

Keywords: anticoagulation heparin biocompatibility haemodialysis haemodiafiltration haemodialyser
single and multiple ascending dose study of ngm120 in healthy adult subjects

Conditions: Cachexia

Summary: the purpose is to evaluate the safety, tolerability, and pk of ngm120 in healthy adult subjects


Eligibility criteria:
inclusion criteria: * normal ecg findings exclusion criteria: * significant history or clinical manifestation of any allergic, dermatological, hepatic, renal, hematological, pulmonary, metabolic, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
same day discharge for video-assisted thoracoscopic surgery (vats) lung surgery

Conditions: Lung Cancer; Surgery

Summary: phase i to evaluate the safety and feasibility of same-day discharge in selected participants undergoing minimally-invasive lung surgery and who receive an enhanced recovery pathway.


Eligibility criteria:
inclusion criteria: * signed or verbal informed consent by participant * male and female adults, age 18 and above * clinical stage i-ii lung cancer (suspected, proven, unproven), or secondary pulmonary malignancy * bmi \< 35 * ecog 0-1 * eligible for surgery and lung cancer resection (fev1 \> 60%, dlco \> 60%) * elective vats anatomic resection (segmentectomy or lobectomy), or wedge resection * capable caregiver for discharge home exclusion criteria: * clinical stage iii lung cancer * surgery requiring pneumonectomy * neoadjuvant therapy * active pregnancy or breastfeeding * history of chronic pain syndromes * history of chronic opioid use * concomitant major surgery indicated with current admission to hospital * anticipated intraoperative complication including conversion to thoracotomy, major bleeding requiring blood transfusion, extensive adhesiolysis, injury to mediastinal structures, airway injury, nerve injury (phrenic, recurrent) * need for epidural or patient-controlled intravenous analgesia * need for urinary catheter

Keywords: same day discharge video-assisted thoracoscopic surgery (vats) minimally invasive surgery enhanced recovery pathway
comparison of intracorporeal and extracorporeal anastomoses for minimally invasive right colectomy

Conditions: Colonic Neoplasms; Crohn Disease

Summary: the primary objective of this study is to retrospectively compare the perioperative and short-term (discharge through 30 days) outcomes of intracorporeal and extracorporeal anastomosis in minimally invasive right colectomies for benign and malignant disease. the secondary objective of this study is to retrospectively compare the rates of incisional hernia (up to 6 month post procedure) between intracorporeal and extracorporeal arms.

this is a multi-center, retrospective chart review study of all consecutive cases of right colectomy performed by participating surgeons at their respective institutions that meet all inclusion and exclusion criteria. all cases of right colectomy performed with intracorporeal or extracorporeal anastomoses or via laparoscopic or robotic platforms that meet the study inclusion and exclusion criteria, will be considered for inclusion. the chart review will be performed in a reverse chronological order starting at a minimum of 30 days prior to irb approval of the study at the site until the number of robotic-assisted and laparoscopic cases to be included per surgeon has been met. study initiation at the participating site will occur once a research agreement has been executed between intuitive surgical and the participating institution/investigator and irb approval has been obtained. it is anticipated that the retrospective chart review will span the period between january 1, 2010 through 30-days prior to irb approval of the study in 2016. baseline patient characteristics, perioperative and post-operative short term clinical and pathological outcomes, and incisional hernia data will be obtained from hospital records for a total of up to approximately 1000 robotic and laparoscopic cases, among the 4 subgroups: robotic-assisted right colectomy with intracorporeal anastomosis (rrcia), robotic-assisted right colectomy with extracorporeal anastomosis (rrcea), laparoscopic right colectomy with intracorporeal anastomosis (lrcia) and laparoscopic right colectomy with extracorporeal anastomosis (rrcea). since the data will have been de-identified, and is archival in nature, there will be no active subject recruitment.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients with benign or malignant right colon disease * patients who have undergone robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to mid-transverse colon exclusion criteria: * patients with perforated, obstructing or locally invasive neoplasm (t4b) * emergency procedures * patients undergoing right colectomy as a secondary procedure * patients undergoing radiation therapy for malignant neoplasia before and after procedure
efficacy study of nivolumab plus ipilimumab or nivolumab plus chemotherapy against chemotherapy in stomach cancer or stomach/esophagus junction cancer

Conditions: Gastric Cancer; Gastroesophageal Junction Cancer; Esophageal Adenocarcinoma

Summary: the main purpose of this study is to compare how long patients with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab and chemotherapy compared with patients receiving chemotherapy alone.


Eligibility criteria:
inclusion criteria: * male or female at least 18 years of age * must have gastric cancer or gastroesophageal junction cancer that cannot be operated on and that is advanced or has spread out * did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their disease within the last 6 months * must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work * must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study exclusion criteria: * presence of tumor cells in the brain or spinal cord that have not been treated * active known or suspected autoimmune disease * any serious or uncontrolled medical disorder or active infection * known history of positive test for human immunodeficiency virus (hiv) or known acquired immunodeficiency syndrome (aids) * any positive test result for hepatitis b or c indicating acute or chronic infection other protocol-defined inclusion/exclusion criteria apply